NCT03300713

Brief Summary

The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,504

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Dec 2017Dec 2026

First Submitted

Initial submission to the registry

September 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 2, 2017

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

9 years

First QC Date

September 28, 2017

Last Update Submit

September 30, 2022

Conditions

Child Behavior DisordersMother-child RelationsDepression, Postpartum

Keywords

Mass screeningPediatrician training

Outcome Measures

Primary Outcomes (1)

  • Frequency of pathological Alarm Distress BaBy (ADBB) scores

    in 12-month-aged children.

Secondary Outcomes (7)

  • Frequency of pathological Alarm Distress BaBy (ADBB) scores

    in 4, 9 and 24 month-aged children

  • Frequency of digestive disorders

    in 4, 9, 12 and 24 month-aged children

  • Number of daytime sleep hours

    in 4, 9, 12 and 24 month-aged children

  • Number of nighttime awakenings

    in 4, 9, 12 and 24 month-aged children

  • Scores on maternal self-evaluation scales (Likert scales)

    at 12 and 24 months postpartum

  • +2 more secondary outcomes

Study Arms (2)

F+ group (Mocitraining program)

EXPERIMENTAL

including 8 pediatricians' clusters. F+ pediatricians will attend a specific training focused on mother-child interactions, maternal psychiatric disorders, particularly PND screening and early interventions for non-psychiatric physician.

Other: MOCITRAINING program

F- group (usual follow-up)

SHAM COMPARATOR

grouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening

Other: usual follow-up

Interventions

MOCITRAINING programOTHER

The program is clinical and psychometric tools for screening for interactions and postpartum psychiatric disorders. The program will expose the existing care arrangements and the different possible orientations of the families according to the identified problem.

F+ group (Mocitraining program)
usual follow-upOTHER

usual follow-up

F- group (usual follow-up)

Eligibility Criteria

Age23 Days - 37 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Each child will be included WITH his biological mother at the first-month visit after birth.
  • Age: 1 month + / - 15 days (child), accompanied by his biological mother
  • Mother able to read French;
  • Signed consent letter after complete information of parents about the MOCITRAINING study, its principle, advantages and disadvantages.

You may not qualify if:

  • Preterm babies.
  • Children from a twin or multiple pregnancy.
  • Children with somatic diagnosis explaining the presence of digestive, sleeping or interactional disorders.
  • Refusal to participate after clear information about the study;
  • Refusal to sign the consent letter;
  • Refusal to be informed of a diagnostic hypothesis;
  • Participants not covered by the Social Security system;
  • Participants incapable of consenting or under legal protection (guardianship or curatorship).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Lille, France

RECRUITING

MeSH Terms

Conditions

Child Behavior DisordersDepression, Postpartum

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood Disorders

Study Officials

  • Renaud Jardri, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud Jardri, MD,PhD

CONTACT

(0) 320 446 747renaud.jardri@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 3, 2017

Study Start

December 2, 2017

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)